Fuji Film 01000007 User Manual

Flat Panel Sensors
For Safe Operation
RIC 35G RIC 43G RIC 35C RIC 43C RIC 24C
Operation Manual
1st Edition : March 2017
System
Conguration
Basic Operation
Daily Inspection and Maintenance
Appendix
Maintenance and Inspection
This Operation Manual describes details on how to operate the at panel sensor
and cautions to be observed when operating it.
After reading this manual, store it nearby the at panel sensor so that you can see
it whenever necessary.
Flat Panel Sensors Operation Manual 897N200608
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Introduction
CAUTIONS
The indirect-conversion at panel sensor is a device which acquires a general radiograph. The at panel sensor is a component of RIC.
Available at panel sensor is RIC 35G/RIC 43G/RIC 35C/RIC 43C/RIC 24C.
RIC 35G, RIC 43G, RIC 35C, RIC 43C and
Wireless communication mode or wired communication mode is available. When used in wireless
communication mode, an access point and battery pack (optional) are required. Each at panel sensor complies with IEC 62220-1 (MEDICAL ELECTRICAL EQUIPMENT ­CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - ) as a general X-ray radiography equipment.
The detector of at panel sensors features 150 micron pixel pitch, a wide 16-bit dynamic range and exposure times up to 3.8 seconds.
This Operation Manual includes descriptions of matters necessary when using the at panel sensor such as the equipment overview, operation procedures and precautions to observe, as well as daily
inspections and maintenance. Accompanying documents were originally drafted in the English language.
RIC 24C
:
Installation may only be conducted by authorized service personnel.
1. No part or all of this manual may be reproduced in any form without prior permission.
2. The information contained in this manual may be subject to change without prior notice.
3. INNOLUX Corporation shall not be liable for malfunctions and damages resulting from installation, relocation, remodeling, maintenance, and repair performed by other than dealers specied by INNOLUX Corporation.
4. INNOLUX Corporation shall not be liable for malfunctions and damages of INNOLUX
Corporation products due to products of other manufacturers not supplied by INNOLUX Corporation.
5. INNOLUX Corporation shall not be liable for malfunctions and damages resulting from remodeling, maintenance, and repair using repair parts other than those specied by
INNOLUX Corporation.
6. INNOLUX Corporation shall not be liable for malfunctions and damages resulting from negligence of precautions and operating methods contained in this manual.
7. INNOLUX Corporation shall not be liable for malfunctions and damages resulting from use under environment conditions outside the range of using conditions for this product such as
power supply, installation environment, etc. contained in this manual.
8. INNOLUX Corporation shall not be liable for malfunctions and damages resulting from natural disasters such as res, earthquakes, oods, lightning, etc.
This system is classied as a medical device under EC Directive 93/42/EEC.
Process waste correctly, as stipulated by local law or any regulations that apply.
Caution : Rx Only in the United States (Federal law restricts this device to sale by or on the order
of a physician.)
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Open-Source Software Contained in This Product
This product contains third party’s software that is made available as open source software or free software.
This software is provided “as is” with no warranty of any kind as to its merchantability or tness for any
particular purpose.
For the information on open source software contained in this product, please see the attached DVD. Source codes for certain type of open source software used in this product are available at delivery cost.
If you would like to receive such source codes, please contact INNOLUX dealer or the service representatives at the agency from which you purchased this product. (Please be noted that any inquiries concerning the contents of source codes should be directed to original licensors of open source
software.)
Note : INNOLUX has successfully performed verication and validation testing on all third party
software and has conrmed its suitability to be used in this system.
Trademarks
All company names and product names described in this manual are the trademarks or registered
trademarks of INNOLUX Corporation or their respective holders. Windows is the registered trademark of US Microsoft Corporation in the U.S.A. and other countries.
Copyright © 2016-2017 INNOLUX Corporation. All rights reserved.
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Contents
Introduction ...........................................................................................................................iii
Chapter 1 For Safe Operation
1.1 Safety ...................................................................................................................... 1-1
1.2 Electromagnetic Compatibility (EMC) ......................................................................1-8
1.2.1 RIC ...........................................................................................................................1-8
Chapter 2
2.1 Flat Panel Sensor ....................................................................................................2-1
2.1.1 System Conguration ..............................................................................................2-1
2.2 Names and the Functions .......................................................................................2-2
2.3 Locations of Labels and Signs ................................................................................2-3
2.3.1 Locations of Labels ..................................................................................................2-3
2.3.2 Safety and Other Symbols .......................................................................................2-5
2.3.3 Symboles de sécurité et autres ...............................................................................2-6
System Conguration (Product Overview)
Chapter 3 Basic Operation
3.1 Preparing the Flat Panel Sensor ............................................................................. 3-1
3.1.1 Type of Flat Panel Sensor .......................................................................................3-1
3.1.2 Number of the Connectable Flat Panel Sensors .....................................................3-1
3.1.3 Inserting/Removing the Flat Panel Sensor into/
from the Radiographic Examination Stand ..............................................................3-1
3.1.4 Charging the Battery Pack for the Flat Panel Sensor ..............................................3-3
3.1.5
3.2 Starting Up and Shutting Down the Flat Panel Sensor ...........................................3-6
3.2.1 Starting Up ..............................................................................................................3-6
3.2.2 Performing an Exposure .........................................................................................3-6
3.2.3 Shutting Down ........................................................................................................3-6
Installing/Removing the Battery Pack for the Flat Panel Sensor .................................... 3-4
Chapter 4 Daily Inspection and Maintenance
4.1 Daily User Inspection and Maintenance ......................................................................4-1
4.1.1 Periodical Inspection ................................................................................................4-1
Appendix A Specications
A.1 Specications ..........................................................................................................A-1
A.1.1 Reduced Equivalent (Flat Panel Sensor) ................................................................ A-1
A.1.2 Power Supply Conditions ........................................................................................ A-1
A.1.3 Environmental Conditions ....................................................................................... A-1
A.1.4 Image Performance ................................................................................................ A-2
A.1.5 Load Restriction ...................................................................................................... A-2
A.1.6 Radio Waves .......................................................................................................... A-2
A.2 External View and Weight .......................................................................................A-3
A.2.1 Flat Panel Sensor ................................................................................................... A-3
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Appendix O Use of Optional Items
O.1 Optional Items ....................................................................................................... O-1
Maintenance and Inspection
Radio frequency (RF) compliance information
Compliance with Part 15 of FCC Rules and Industry Canada licence-exempt RSS
standard(s). .......................................................................................................................... 2
Compliance with 2014/53/EU ............................................................................................... 4
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Chapter 1
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING/AVERTISSEMENT
WARNING
For Safe Operation
1.1 Safety
Before using the at panel sensor, read this section thoroughly to ensure that you use the product properly.
Electric Shock Warnings and Cautions
This product is internal power supply equipment. To avoid electric shocks, users should always take the following precautions:
● Do not open any covers when it is not necessary.
● Install the equipment in a location where it will not be exposed to water.
Do not install the battery pack with dew condensation on the at panel sensor. Otherwise, re or electric shock may result.
Do not use the equipment in a location where metal particles could come into the equipment. This may cause an electric shock.
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For Safe Operation
Do not disassemble or remodel the equipment. Otherwise, re or electric shock may result. Keep away from the parts inside the product, which may cause electric shock. If you touch
them accidentally, death or severe injury may result.
Do not hit or drop the at panel sensor or subject it to severe shock. Otherwise, the at panel sensor may be damaged. If the damaged at panel sensor is used, re or electric shock may result. In addition, do not apply strong pressure onto the at panel sensor. If applied, the at
panel sensor deforms and the waterproof function may be compromised.
Do not use the at panel sensor without the battery packs. If the battery packs are not attached, an electric shock may result.
N’utilisez pas le détecteur à panneau plat sans les batteries. Si les batteries ne sont pas
connectées, un choc électrique risque de se produire.
Make sure to use the optional parts and accessories recommended by INNOLUX Corporation.
Failure to use the optional parts and accessories recommended by INNOLUX Corporation may
result in damage to the at panel sensor and/or electric shock and injury. For details on the precautions for using the optional parts and accessories recommended by
INNOLUX Corporation, see the Operation Manual for the optional parts and accessories.
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1
CAUTIONS
WARNING
WARNING
WARNING
AVERTISSEMENT
CAUTIONS
Keep the at panel sensor away from patient’s body uids, chemicals, water, etc. Otherwise, it may become damaged, causing re or electric shock. If necessary, protect the at panel sensor by covering it with a disposable bag.
Explosion Warnings
For Safe Operation
Because the at panel sensor is not explosion-proof, do not use combustible and explosive gases near the at panel sensor.
Flammable gasses may stay in the room after disinfection. If you turn the system on just after disinfection, ensure that the room is well ventilated before powering on the system.
Warnings for Abnormalities
If any of the following occurs, immediately remove the battery pack, and then contact our ofcial dealer or INNOLUX Representative.
● When smoke, strange odor, or abnormal sound is present.
● When a foreign object (such as a metal object) or liquid enters the product.
● When the equipment is dropped or hit and is damaged.
Avertissements relatifs aux anomalies
Si l’une des conditions répertoriées ci-après se produit, retirez immédiatement la batterie, puis
contactez notre revendeur agréé ou notre représentant INNOLUX.
● En cas de présence de fumée, d’une odeur étrange ou d’un bruit anormal.
● En cas de pénétration d’un corps étranger (comme un objet métallique) ou d’un liquide dans
le produit.
● En cas d’endommagement de l’équipement suite à une chute ou à un impact.
Installation Precautions
Do not install the equipment in a location with the following conditions.
● Where the temperature changes sharply.
● Close to heat sources such as a heater.
● Where the equipment may be exposed to water due to water leakage or ingress.
● Where corrosive gas may be generated.
● Where there is excessive dust.
● Where the equipment is subject to frequent or excessive vibration/shock.
● Where the equipment is exposed to direct sunlight.
● Where there is no ventilator.
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CAUTIONS
Use the at panel sensor on a at place. Otherwise, the at panel sensor may fall down,
CAUTIONS
CAUTIONS
CAUTIONS
WARNING
WARNING
WARNING
WARNING
WARNING
causing damage to the at panel sensor or personal injury.
For veterinary or mobile applications, contact our ofcial dealer or INNOLUX Representative.
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When the devices are used outdoors in wireless communication mode, contact our ofcial
dealer or INNOLUX Representative.
CAUTIONS/ATTENTION
Do not place any object in a place where removal of the power cable is prevented.
Ne placez aucun objet à un emplacement gênant le débranchement du câble d’alimentation.
To ensure optimal image quality, it is recommended that you do not use the at panel sensor near devices (motor, transformer, switching supply, etc.) that generate electromagnetic noise.
Connection Instructions
Make sure that the devices to be connected to the at panel sensor are authorized for connection.
For Safe Operation
When the at panel sensor is used in wired communication mode, connect it only to the devices specied by our ofcial dealer or INNOLUX Representative.
System Isolation Instructions
To ensure complete system isolation, never install any unauthorized accessories or other such items.
When it is necessary to install authorized accessories or optional items, contact our ofcial dealer
or INNOLUX Representative.
Keep equipment other than those used for patients out of their reach to ensure appropriate
system isolation.
In normal use, have a patient take a proper positioning for exposure. The operator should operate the system in a place where safety from radiation is ensured. The operator should also make sure before exposure that no one but the patient is in the exposure area and the operating area of the system.
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1
CAUTIONS
WARNING
WARNING
CAUTIONS
CAUTIONS
CAUTIONS
Software Precautions
Do not install additional software to the system. Do not uninstall any of the software preinstalled in the system. The system is preinstalled with the appropriate software. If other software is installed or if the
existing software is uninstalled, various operational errors may result.
For Safe Operation
Disinfection Instructions
Conrm that the respiratory density of disinfectant including solvent is under legal regulation. Certain disinfectants may damage health. When using a disinfectant, follow instructions
supplied by the manufacturers.
Do not use the following disinfectants at the time of disinfection. Doing so may damage the at panel sensor and quality, performance and safety of the at panel sensor cannot be assured.
● Chloric disinfectant which is strongly corrosive to metals and rubber parts.
● Disinfectant whose uses on metals, plastics, and coating are forbidden according to the
● Formalin gas and disinfectant sprays that may get inside the at panel sensor.
Disinfectant ethanol is recommended for disinfection. Carefully read the instructions and cautions supplied with the disinfectant before use. For details on the disinfectant, contact a INNOLUX dealer or the service representatives at the
agency from which you purchased the disinfectant.
instructions supplied with the disinfectant.
If at panel sensor is not disinfected, it may lead secondary infection.
Be sure to disinfect with ethanol after use.
Clean the sensor unit of the at panel sensor with ethanol for disinfection, etc. for each patient
to prevent infection.
Precautions for Charging the Battery Pack
● Use the battery charger recommended by INNOLUX Corporation.
For details on operations, refer to the instruction manual for the battery charger.
● Do not charge the battery pack near re or under strong sunshine. If the built-in protection
mechanisms are activated by a high temperature, the battery pack cannot be charged. Also, if the built-in protection mechanisms are damaged, the battery pack may be charged with extremely high current and voltage, and abnormal chemical reactions may occur inside the battery pack, causing it to overheat, emit smoke, explode or ignite.
● To charge the battery pack, be sure to use the designated battery charger and to observe
the charging conditions specied by INNOLUX Corporation. If the battery pack is charged in other conditions (temperature or voltage/current higher than specied, remodeled battery charger, etc.), the battery pack may be overcharged or charged with extremely high current, and abnormal chemical reactions may occur inside the battery pack, causing it to overheat, emit smoke, explode or ignite.
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● Immediately stop charging the battery pack, if charging is not completed within the specied
WARNING
CAUTIONS
time. Otherwise, the battery pack may overheat, emit smoke, explode or ignite.
● Do not use the at panel sensor near the power cable.
● Do not use a faulty or broken battery charger or AC adapter.
Battery Pack Instructions
1
● Battery pack requires regular checkup and replacement. Battery capacity begins to wane
after a period of time.
● If this equipment is not in use for while, store it with the battery pack removed. Not
removing the battery pack may cause malfunction.
Observe the following precautions when using the battery pack (optional).
● The battery pack is used with the at panel sensor. Do not use them in other combinations.
● Charge the battery pack only with the designated battery charger. If the battery pack is
charged under the charging conditions (voltage, current and charging method) different from those specied by INNOLUX Corporation, the battery pack may emit smoke, ignite, explode or leak uid.
● Store the battery pack in a cool and dark place. Recharge the stored battery pack every six
months or every year. Otherwise a decrease in battery capacity or other problems may result.
● Do not leave the removed battery pack in the car or other places exposed to high
temperature. If the battery pack is used or stored in a place where it is exposed to high temperature, the battery pack may emit smoke, ignite, explode or leak uid.
● Use or store the battery pack only in the environmental conditions specied by INNOLUX
Corporation. If the battery pack is used or stored in a place where it is exposed to high temperature, the battery pack may emit smoke, ignite, explode or leak uid.
● When disposing of the battery pack, consult our ofcial dealer or INNOLUX Representative.
● Do not disassemble or remodel the battery pack. The battery pack is equipped with built-in
safety and protection mechanisms. If they are damaged, the battery pack may overheat, emit smoke, explode or ignite.
● Be careful not to drop the battery pack. The patient may be injured.
● Do not touch the terminal of the battery pack directly. There is a risk of electric shock.
● Do not connect the positive (+) and negative (-) terminals with a wire or any metal object.
Do not carry or store the battery pack together with metal objects such as necklaces or hairpins. Otherwise, the battery pack may short-circuit and overcurrent may ow, causing the battery pack to overheat, emit smoke, explode or ignite. Metal objects such as necklaces
or hairpins may also become hot.
Do not throw the battery pack into re or expose it to excessive heat. Otherwise, its insulator may melt, its gas release vent or safety mechanisms may be damaged, and/or its electrolyte may catch re, causing the battery pack to overheat, emit smoke, explode or ignite.
● Do not use or leave the battery pack in a place where it is exposed to high temperature (80°C
or higher), such as re or a heater. If the resin separator is damaged due to heat, the battery pack may short-circuit, causing it to overheat, emit smoke, explode or ignite.
● Do not immerse the battery pack in water or seawater, and do not allow it to become wet.
If the built-in protection mechanisms are damaged, the battery pack may overheat, emit smoke, explode or ignite.
● Do not pierce the battery pack with a nail, hit it with a hammer, or step on it. Otherwise, the
battery pack may be damaged or deformed and short-circuit, causing it to overheat, emit smoke, explode or ignite.
● Do not subject the battery pack to strong impact or throw it. If the built-in protection
mechanisms are damaged, the battery pack may be charged with extremely high current and voltage, and abnormal chemical reactions may occur inside the battery pack, causing it to overheat, emit smoke, explode or ignite.
For Safe Operation
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● Do not use an apparently damaged or deformed battery pack. Otherwise, the battery pack
WARNING
CAUTIONS
CAUTIONS
● Do not solder the battery pack directly. Otherwise, its insulator may melt, or its gas release
● Do not reverse the positive (+) and negative (-) terminals. Otherwise, the battery pack may
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● The battery pack has a predetermined polarity. If you cannot connect the battery pack to the
For Safe Operation
● Do not connect the battery pack to an electrical outlet or cigarette lighter socket in a car.
● Do not use the battery pack for equipment other than those specied. Otherwise, the
● If the electrolyte leaked from the battery pack enters the eyes, do not rub them. Wash the
● Do not use the battery pack in combination with a primary battery such as a dry battery or
● Do not put the battery pack in a microwave oven or high-pressure container. Otherwise, the
● If the battery pack leaks or emits an unusual odor, remove it from re immediately.
● If you notice an unusual odor, heat, discoloration, deformation or any other abnormality
● Do not use the battery pack exposed to a strong magnetic eld of an MRI system, etc.
● Do not use the battery pack immersed in liquid.
may overheat, emit smoke, explode or ignite.
vent or safety mechanisms may be damaged, causing the battery pack to overheat, emit smoke, explode or ignite.
be reverse-charged during charging. As a result, abnormal chemical reactions may occur inside the battery pack, or extremely high current may ow during discharging, causing it to overheat, emit smoke, explode or ignite.
battery charger or other equipment, do not connect the battery pack forcefully. Make sure that the terminals are correctly oriented. If the battery pack is connected in reverse, it will be reverse-charged, and abnormal chemical reactions may occur inside the battery pack, causing it to overheat, emit smoke, explode or ignite.
Overcurrent may ow to the battery pack due to high voltage applied, causing the battery pack to overheat, emit smoke, explode or ignite.
guaranteed performance will be reduced and/or the service life will be shortened. Depending on the equipment to which the battery pack is connected, extremely high current may ow, causing the battery pack to be damaged, overheat, emit smoke, explode or ignite.
eyes immediately with clean water such as tap water, and consult a doctor. Otherwise, eye injury may result.
other battery of a different capacity, type and/or brand. Otherwise, the battery pack may be overcharged during charging, and abnormal chemical reactions may occur inside the battery pack, causing it to overheat, emit smoke, explode or ignite.
battery pack may be rapidly heated or damaged, causing it to overheat, emit smoke, explode or ignite.
Otherwise, the leaked electrolyte may catch re, causing the battery pack to overheat, emit smoke, explode or ignite.
during use, charging or storage, remove the battery pack from the equipment or battery charger, and stop using it. Otherwise, the battery pack may overheat, emit smoke, explode or ignite.
Other Warnings and Cautions
No modication of this equipment is allowed.
Install the system in accordance with what is provided by IEC 60601-1:2005 + A1:2012 Chapter
16. Contact our ofcial dealer or INNOLUX Representative for installation (except the at panel
sensor) of the system.
Do not hit or drop the at panel sensor. Otherwise, injury or damage to images, etc. may result.
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CAUTIONS
Be sure to inspect the system periodically.
CAUTIONS
CAUTIONS
CAUTIONS
CAUTIONS
To assure optimum performance of the at panel sensor, it is necessary to systematically
perform maintenance and inspection. For information on maintenance and inspection, contact
our ofcial dealer or INNOLUX Representative.
Do not perform maintenance and inspection while the equipment is used for a patient.
The institution where the equipment is installed is responsible for its use and maintenance. In addition, this equipment should not be used by persons other than doctors or suitably
trained staff.
Be careful not to expose the at panel sensor to X-ray without a subject.
Although the at panel sensor conforms to IPX3, no warranty is given as to the prevention of water intrusion in the at panel sensor. If the at panel sensor is splashed with water, wipe off moisture and ensure that the at panel sensor is completely dry before use.
1
For Safe Operation
Contraindications and Prohibitions
No contraindications present.
Classication
● According to the type of protection against electrical shock Internal power supply equipment
● According to the degree of protection against electrical shock
Type B applied part
● According to the degree of protection against harmful ingress of water
IP00 (The at panel sensor conforms to IPX3)
● According to the degree of safety of application in the presence of a ammable anesthetics mixture with air or with oxygen or nitrous oxide.
Equipment not suitable for use in the presence of a ammable anesthetics mixture with air or with
oxygen or nitrous oxide.
● According to the mode of operation
CONTINUOUS OPERATION
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1.2 Electromagnetic Compatibility (EMC)
WARNING
1.2.1 RIC
1
For Safe Operation
This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2 (EN 60601-1-2), Medical Device Directive 93/42/EEC.
These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.
This equipment generates, uses and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to other devices in the vicinity.
However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by tuning the equipment off and on, the user is encouraged to try to correct the interference by one or
more of the following measures:
• Reorient or relocate the receiving device.
• Increase the separation between the equipment.
• Connect the equipment into an outlet on a circuit different from that to which the other device(s)
are connected.
If the problem cannot be solved with the above measures, stop using this equipment and consult the manufacturer, our ofcial dealer or INNOLUX Representative for help.
● Do not place devices generating electromagnetic wave near this equipment.
● If a device(s) other than those specied is connected, predetermined EMC performance cannot be guaranteed.
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